Therapeutic Clinical Intelligence-Inflammatory Bowel Disease

Table of Contents

• Scope of Assessment
• Overview of Competitive Landscape for IBD
• Products Profiled in IBD Clinical Intelligence Report
• Snap-Shot of Ongoing Clinical Trials in Crohn' s Disease and Ulcerative Colitis
• Ongoing Clinical Trials-Key Players in IBD
• Key Competitor Product Profiles
• Key Competitor Filing and Approval Timeline
• Overview of Key Competitor Pivotal Trial Designs
• Analysis of Study Time-to-Complete & Number of Patients for Pivotal Trials in Crohn' s Disease

• Product Overview- Competitor Snapshot
• Remicade' s Path-to-Market & Development Timeline
• Remicade (Infliximab) Crohn' s Disease
  • Phase I Study: Design & Results Overview
  • Phase II (Study T11): Design & Results Overview
  • Phase II Study Design (T16)
  • Phase II Study Design (T16)-Continued
  • Phase II Study Results (T16)
  • Phase II Study Results (T16): Open Label Analysis
  • Remicade Phase III Trial Design (ACCENT-1)
  • Remicade Phase III Trial Results (ACCENT-1)
  • Phase III Trial Design (ACCENT-2)
• Remicade Phase III Trial Results (ACCENT-2)
  • Remicade Study Design in Pediatric Patients Crohn' s Disease
  • Remicade Study Results in Pediatric Patients with Crohn' s Disease
  • Ongoing Studies Industry-sponsored with Remicade Clinical in Crohn' s Disease
  • Ongoing Studies Industry-sponsored with Remicade in Crohn' s Disease
  • Remicade (Infliximab) Ulcerative Colitis
  • Phase III Trial Design (ACT-1 & ACT-2)
  • Phase III Trial Results (ACT-1)
  • Phase III Trial Results (ACT-2)
  • Phase III Trial Results (ACT-1 & ACT-2)
  • Ongoing Studies with Remicade in Ulcerative Colitis

• Humira (Adalimumab) Crohn' s Disease
  • Humira Product Overview- Competitor Snapshot
  • Phase II Study Design and Results
  • Phase II Study Design
  • Phase II Study Results
  • Phase II Study Design & Results
  • Phase III Study Design (CHARM)
  • Phase III Study Results (CHARM)
  • Phase III Study Design (CLASSIC I & II)
  • Phase III Study Results (CLASSIC-1 & CLASSIC-2)
  • Phase III Study Results (CLASSIC-2)
  • Phase III Study Design (GAIN)
  • Phase III Study Results (GAIN)
  • Ongoing Studies in Crohn' s Disease
  • Ongoing Phase III Study in Crohn' s Disease
• Humira (Adalimumab) Ulcerative Colitis
  • Phase II/III Ongoing Study
• Cimzia (certolizumab) Crohn' s Disease
  • Product Overview: Competitor Snapshot
  • Phase III Study Design (PRECiSE 1&2)
  • Phase III Study Results (PRECiSE 1&2)
  • Ongoing Studies in Crohn' s Disease
• Tysabri (natalizumab) Crohn' s Disease
  • Product Overview- Competitor Snapshot
  • Phase II Study Design
  • Phase II Study Results
  • Phase III Study Design (ENACT-1)
  • Phase III Study Results (ENACT-1)
  • Phase III Study Design (ENACT-2)
  • Phase III Study Results (ENACT-2)
  • Phase III Study Design (ENCORE)
  • Phase III Study Results (ENCORE)
• Orencia (abatacept) Crohn' s Disease
  • Orencia Product Overview: Competitor Snapshot
  • Orencia Phase III Study Design
• Orencia (abatacept) Ulcerative Colitis
  • Orencia Phase III Study Design
• Nuvion (Visilizumab) Ulcerative Colitis
  • Nuvion Product Overview: Competitor Snapshot
  • Nuvion Phase I/II Study Design & Results
  • Nuvion Ongoing Phase II/III Study in Ulcerative Colitis
  • Nuvion Ongoing Studies in Ulcerative Colitis

• Rituxan (rituximab) Ulcerative Colitis
  • Rituxan: Product Overview: Competitor Snapshot
  • Rituxan Phase II/III Ongoing Study Design
• ABT-874 Crohn' s Disease
  • ABT-874 Product Overview: Competitor Snapshot
  • ABT-874 Phase II Study Design
  • ABT-874 Phase II Study Results
• MLN-02 Ulcerative Colitis
  • MLN02: Product Overview- Competitor Snapshot
  • MLN-02 Phase II Study Design
  • MLN-02 Phase II Study Results
• Traficet-EN (CCX282-B) Crohn' s Disease
  • Traficet-EN Product Overview-Competitor Snapshot
  • Traficet-EN Phase II Study Design
  • Traficet-EN Phase II Study Results
  • Traficet-EN Ongoing Study in Crohn' s Disease
• Firategrast (683699) Crohn' s Disease
  • Firategrast Product Overview: Competitor Snapshot
  • Firategrast Phase II Study Design
• MDX-1100 Crohn' s Disease
  • MDX-1100 Product Overview: Competitor Snapshot
  • MDX-1100 Ongoing Study in Crohn' s Disease
  • MDX-1100 Ongoing Study in Crohn' s Disease (con' t)

• AZD-9056 IBD (Undisclosed)
  • AZD-9056 Product Overview: Competitor Snapshot
  • AZD-9056 Ongoing Study (POPCORN)
• Semapimod (CNI-1493) Crohn' s Disease
  • Semapimod Product Overview: Competitor Snapshot
  • Semapimod (CNI-1493) Clinical Trials:
• RDP-58 127
  • RDP58 Product Overview: Competitor Snapshot
  • RDP-58 Phase II Clinical Trial Design & Results- Ulcerative Colitis

• References
• References (Continued)
• Disclaimer
• Report Licensing

• Figure 1: Overview of IBD Competitive Landscape
• Figure 2: Snap-Shot of Ongoing Clinical Trials in IBD
• Figure 3: Ongoing Studies of Key Players in IBD
• Figure 4: Key Competitor Filings & Approval Timeline
• Figure 5: Analysis of Study Time-to-Complete for Pivotal Trials in Crohn' s Disease
• Figure 6: Trial Sizes- Total Number of Patients in Pivotal Studies

• Table 1: Products Profiled in the Report
• Table 2: Key Competitor Product Profiles
• Table 3: Overview of Key Competitor Pivotal Trial Designs